NCT01520688

Effect of Flovent Discus vs QVAR vs Pulmicort Flexhaler on Short Term Growth

A Randomized, Cross Over Study Evaluating the Effect of Flovent Discus 100 mcg BID vs QVAR 80 mcg BID vs Pulmicort Flexhaler 180 mcg BID on Short Term Growth in Pediatric Subjects With Asthma

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: West Penn Allegheny Health System · Academic / Other
• Sex: All
• Age: 6 Years – 11 Years
• Healthy volunteers: Accepted

Summary

Children with mild persistent asthma that have asthma symptoms once or twice a week and use a daily controller, while children with mild intermittent asthma rarely have asthma symptoms and do not use a daily controller. Inhaled corticosteroids are the standard treatment for mild peristent asthma. The purpose of this study is to measure children rate of growth while on different inhaled corticosteroids.

Detailed description

A randomized, cross over study evaluating the effect of Flovent Discus 100 mcg BID vs QVAR 80 mcg BID vs Pulmicort Flexhaler 180 mcg BID on short term growth in pediatric subjects with asthma. Objectives: 1. The primary objective of this study is to compare the effect of Flovent Diskus 100 mcg BID versus Pulmicort Flexhaler 180 mcg BID on short-term lower leg growth velocity as measured by knemometry in pediatric subjects with mild asthma. 2. The secondary objective of this study is to compare the effect of Flovent Diskus 100 mcg BID versus QVAR 80 mcg BID on short-term lower leg growth velocity as measured by knemometry in pediatric subjects with mild asthma. Aims: 1. The primary aim is to show that there is a growth suppressive effect of Pulmicort Flexhaler 180 mcg BID versus Flovent Diskus 100 mcg BID in children with mild asthma. 2. The secondary aim to show that there is a growth suppressive effect of QVAR 80 mcg BID versus Flovent Diskus 100 mcg BID in children with mild asthma. Hypotheses: 1. The primary hypothesis is that treatment with Pulmicort Flexhaler 180mcg BID as compared to Flovent Diskus 100 mcg BID has a growth suppressive effect on lower leg length as assessed by knemometry in pediatric subjects with mild asthma. 2. The secondary hypothesis is that treatment with QVAR 80 mcg BID as compared to Flovent Diskus 100 mcg BID has a growth suppressive effect on lower leg length as assessed by knemometry in pediatric subjects with mild asthma.

Conditions

• Asthma

Interventions

Type	Name	Description
DRUG	Fluticasone, Budesonide, Beclomethasone	Fluticasone 100 mcg bid Budesonide 180 mcg bid Beclomethasone 80 mcg bid
DRUG	Fluticasone, Beclomethasone, Budesonide	Fluticasone 100mcg BID Beclomethasone 80 mcg BID Budesonide 180 mcg BID
DRUG	Budesonide, Fluticasone, Beclomethasone	Budesonide180 mcg BID Fluticasone 100 mcg Beclomethasone 80 mcg BID
DRUG	Budesonide, Beclomethasone, Fluticasone	Budesonide 180 mcg BID Beclomethasone 80mcg BID Fluticasone 100mcg BID
DRUG	Beclomethasone, Fluticasone, Budesonide	Beclomethasone 80 mcg BID Fluticasone 100mcg BID Budesonide 180 mcg BID
DRUG	Beclomethasone, Budesonide, Fluticasone	Beclomethasone 80mcg BID Budesonide 180 mcg BID Fluticasone 100mcg BID

Timeline

• Start date: 2012-02-01
• Primary completion: 2016-02-01
• Completion: 2016-02-01
• First posted: 2012-01-30
• Last updated: 2020-11-18
• Results posted: 2020-10-12

Locations

2 sites across 1 country: United States